Study on Ibrutinib, Fludarabine, and Pembrolizumab for High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03204188

Provider View

This clinical trial is testing a combination of three drugs—ibrutinib, fludarabine, and pembrolizumab—to see if they can effectively treat patients with high-risk or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Patient Parameters

Program Overview

Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are types of cancer that affect B cells, a kind of white blood cell. Some patients with high-risk CLL do not respond well to standard chemotherapy. This study is exploring a new treatment combination of ibrutinib, fludarabine, and pembrolizumab to see if it can better reduce cancer cells and improve the immune system's ability to fight the disease. Ibrutinib is a pill that targets cancer cells, fludarabine is a drug that can help modify cancer and immune cells, and pembrolizumab helps the immune system attack cancer cells. The goal is to achieve a better response than using ibrutinib alone.

Description

This study is testing a new combination of drugs to treat Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), which are cancers of the B cells. Some patients with high-risk CLL do not respond well to standard treatments. High-risk CLL can be due to the cancer returning after treatment or having certain genetic mutations. Ibrutinib is a drug that blocks signals that help cancer cells grow. It is taken as a pill and has shown good results in previous studies. However, it may not eliminate all cancer cells, so combining it with other drugs like fludarabine and pembrolizumab might be more effective. The study aims to see if this combination can lead to a complete response, meaning no signs of cancer. Patients will take ibrutinib continuously, fludarabine for a short period, and pembrolizumab for one year. The study will also check if patients need long-term treatment with ibrutinib based on their response.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
  • Active disease with symptoms like significant weight loss, extreme fatigue, fever, night sweats, worsening anemia, or enlarged spleen or lymph nodes.
  • High-risk disease, including relapsed or refractory CLL/SLL or specific genetic mutations.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate organ function.
  • Willingness to use effective contraception during the study and for 90 days after the last dose if able to have children.
  • Ability to understand the study and provide informed consent.

Exclusion Criteria

  • Transformation of CLL into other types of lymphoma.
  • Recent participation in another clinical trial or treatment with investigational drugs.
  • Recent treatment with certain cancer therapies or major surgery.
  • Current use of systemic steroids or immunosuppressive therapy.
  • Previous treatment with specific drugs like BTK inhibitors or anti-PD-1 agents.
  • Active autoimmune disease requiring treatment in the past two years.
  • Other active cancers or serious medical conditions.
  • Known infections like HIV, hepatitis B, or hepatitis C.
  • Recent active infection requiring treatment.
  • Known bleeding disorders or history of stroke.
  • Use of certain medications that affect drug metabolism.
  • Significant heart disease or other life-threatening conditions.
  • Pregnant or breastfeeding women, or those unwilling to use contraception.
  • Psychiatric or social conditions affecting study participation.
  • Significant liver impairment or recent vaccination with live vaccines.

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